1. ACIP Meeting Update November 4 th 2010 www.ImmunizeTexas.com

2. ACIP Meeting Update

3. ACIP (October 27-28 th, 2010) Topics for meeting –Meningococcal Vaccine –Pertussis Vaccines –Evidence Based Recommendations –Harmonized Child/Adolescent Schedule –Adult Immunization Schedule –Rotavirus Vaccines

4. Meningococcal Conjugate Vaccine Evidence that antibodies do not persist in most people 5 years post vaccination Current strategy of vaccinating 11-12 year olds will not provide protection through peak disease incidence in late adolescence 2 thoughts –Move first vaccination to 15-16 year old cohort –Add booster dose 5 years after 1 st dose at 11- 12 years of age

5. Meningococcal Conjugate Vaccine ACIP recommends routine vaccination of adolescents with meningococcal vaccine beginning at 11-12 years of age with a booster dose at age 16 years of age (5 years after the first dose) For adolescents vaccinated at age 13-15, a one-time booster dose should be given 5 years after the first dose The ACIP separately voted to include the booster dose in the Vaccines for Children (VFC) program.

6. Meningococcal Conjugate Vaccine ACIP also passed a recommendation that persons with HIV, asplenia, and complement component deficiencies should receive a 2 dose series of meningococcal vaccine –Dosing at day 0 and 2 months –This group should be revaccinated every 5 years after the last dose.

7. Pertussis Vaccines Issues for ACIP Consideration Low Coverage levels –Adolescents = 56% (NIS Teen -2009) –Adult = less than 6% (National Health Interview 2008) Adults aged 65 and older not licensed for Tdap vaccine No licensed Tdap vaccine for children 7-9 years of age 2 year interval between last dose of Td and first dose of Tdap

8. Pertussis Vaccines ACIP Recommendations In adolescents and adult, Tdap should be given as soon as feasible; removed time interval between Td and Tdap Children 7-10 years of age who are not fully vaccinated with pertussis (not receive 5 doses Dtap/DTP) should receive 1 dose of Tdap Children 7-10 years who have never been vaccinated should receive 1 tdap, a second dose of td and a 3 rd dose of td.

9. Pertussis Vaccines ACIP Recommendations Adult 65+: –general recommendation for Tdap for those 65+ who have contact with infants under 1 year of age (in place of a Td vaccine) –permissive recommendation for Tdap in place of Td for all other adults 65+ All of these recommendations are off-label use for both licensed Tdap vaccines

10. Guidelines For Evidence Based Recommendations ACIP Evidence Based Recommendation Work Group (EBRWG) proposed the adoption of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) for grading from evidence to recommendations. –The evidence for vaccine efficacy/effectiveness and adverse events would be graded using four levels; A, B, C, and D –The ACIP proposal will include two recommendation categories as well as a no recommendation or unresolved issue category.

11. Guidelines For Evidence Based Recommendations ACIP voted to adopt an evidence-based grading system to accompany new vaccine recommendations. The system will grade the level of scientific evidence supporting the recommendation, from randomized clinical trials to expert opinion.

12. 2011 Childhood and Adolescent Schedule 3 schedules to approve –0-6 years of age –7-18 years of age –“catch-up” schedule Proposed changes –Hep b guidance for children who did not receive a birth dose –PCV 13 added to schedule –Guidance on influenza vaccination (with history of H1N1 taken into consideration) –Interval between Td and Tdap to be reconsidered based on new Tdap recommendations

13. 2011 Childhood and Adolescent Schedule Proposed changes (cont.) –HPV footnotes being condensed –Minimum age for Hep B dose added to catch-up schedule –Guidance for use of Hib vaccine in people 5 years of age and older –Revised abbreviation for meningococcal conjugate vaccine The schedules will be published in the MMWR, the journal Pediatrics (AAP) and the journal American Family Physician (AAFP) in February, 2011 (delayed 1 month due to recent vote)

14. 2011 Adult Schedule First schedule approved in 2002 Proposed changes for 2011 –Seasonal influenza vaccine recommendation to include everyone > 6 months of age –Statement added “a vaccine does not need to be restarted, regardless of the time that has elapsed between doses.” –Several footnote revisions for influenza, MMR, and PPSV –Revised abbreviation for meningococcal conjugate vaccine The schedules will be approved by the ACIP, the American Academy of Family Physician, the American College of Obstetricians and Gynecologist and the American College of Physicians

15. Rotavirus Vaccines Data was presented from several post marketing studies that evaluated the risk of intussusception following vaccination –Studies from Mexico, Australia, and the US Updated presentations from GSK (Rotarix) and Merck (RotaTeq) on vaccines and intussusception. ACIP had no new recommendation; session was for information update and discussion